EXALT Model B Single-Use Bronchoscope

Author(s): Kevin Carroll, MBBS, David Pechman, MD

Boston Scientific received FDA approval for the EXALT Model B Single-Use Bronchoscope on August 10th, 2021

The EXALT Model B Bronchoscope is a single-use bronchoscope developed as an alternative to reusable bronchoscopes.  This bronchoscope has superior quality imaging and suctioning (up to 78% improved) which is vital for bedside procedures. The single use platform allows for quality imaging without the necessity of maintenance and scope repairs associated with the reusable platform. It is sterile directly out of its packaging and does not require any reprocessing. The single use nature of the device reduces risk of infection. The EXALT Model B Bronchoscope has a clamshell design that produces a larger surface area, resulting in superior suction relative to other single use and reusable bronchoscopes.

The Model B is engineered to provide precise articulation with proprietary stability wires and 180 degree tip articulation. The EXALT Model B comes in three sizes: Large (5.8mm), Regular (5.0mm) and Slim (3.8mm), which provide 40%, 78% and 84% more suction power, respectively compared to other similarly sized endoscopes.  The device comes with dynamic light control and bright LEDs designed to produce excellent imaging quality and ease of navigation. The Model B can be connected to a 12.3” high resolution portable monitor.

The FDA has determined that this device is substantially equivalent to the following predicate devices: Ambu aScope 4 Broncho Slim 3.8/1.2, Ambu aScope 4 Broncho Regular 5.0/2.2, Ambu aScope 4 Broncho Large 5.8/2.8, and Ambu aView Monitor.  Non-clinical testing demonstrated substantial equivalency beteen the EXALT Model B and the currently available predicate devices.

The EXALT Model B is FDA approved for the following indications:

1. Secretion management
2. Airway intubation
3. Percutaneous tracheostomy
4. Double lumen endotracheal tube placement
5. Biopsies
6. Single-use in high infection risk patients

The EXACLT Model B is contraindicated for use when bronchoscopy is contraindicated.

References:

1. Hastings, Conn (2021): ‘EXALT Model B Single-Use Bronchoscope: Interview with Dave Pierce, Boston Scientific’; ‘ https://www.medgadget.com/2021/09/exalt-model-b-single-use-bronchoscope-interview-with-dave-pierce-boston-scientific.html ‘
2. Boston Scientific (2021): ‘EXALT Model B Performance’; https://www.bostonscientific.com/en-US/medical-specialties/pulmonology/exalt-b/performance.html
3. Boston Scientific (2021) : ‘Boston Scientific Receives FDA clearance for EXALT Model B Single-Use Bronchoscope’; https://news.bostonscientific.com/2021-08-10-Boston-Scientific-Receives-FDA-Clearance-for-EXALT-TM-Model-B-Single-Use-Bronchoscope
4. FDA (2021): ‘510(k) Summary for EXALT Bronchoscopic Visualization System’; https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211030.pdf